BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCARE CRYOCARE, CRYOPROBE 2.4MM R/ANGLE

    MDR report key: 1930241 · Received November 18, 2010

    Report

    Report Number
    3008262715-2010-00090
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    HEALTHTRONICS INC
    Product Code
    GEH
    PMA / PMN Number
    K060279
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INJURY REPORTED. CURRENT CONDITION OF PT WAS REPORTED AS "NO ISSUE TO REPORT PRESENTLY."

    Description of Event or Problem · 1

    THE PERC-24 WAS PRE-TESTED AND PASSED THE TEST. ONCE THE PROBE WAS PLACED IN POSITION, IT BEGAN TO FREEZE UP THE SHAFT OF THE FIRST FREEZE CYCLE. FREEZE WAS STOPPED, PROBE WAS THAWED, REMOVED AND REPLACED BY A NEW PERC-24.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCARE CRYOCARE, CRYOPROBE 2.4MM R/ANGLE UNIT, CRYOSURGICAL, ACCESSORIES GEH HEALTHTRONICS INC PERC-24 09-0715

    Patients

    Seq Age Sex Outcome Treatment
    1